Vaginal device

ABSTRACT

A vaginal device and method of preventing urinary incontinence is disclosed. The device includes a longitudinal portion having a geometrical centre line, a first end and a second end, the first end being the innermost of the vaginal device during use, at least one supporting portion protruding from the longitudinal portion at the first end, the at least one supporting portion being configured to support against the urethra, through the vaginal wall, at a site located adjacent the maximal urethral pressure point, and a reference member protruding from the longitudinal portion at the second end, wherein the reference member during use is fixated against the vaginal introitus, holding the vaginal device securely fixated inside of the vagina and ensuring the at least one supporting portion is arranged at the intended site. The device further includes a section of the longitudinal portion, arranged between the supporting portion and the reference member, that has a decreasing cross-section towards the reference member and/or has at least one notch, groove and/or slot in an outer surface along an axial direction of the section.

PRIORITY CLAIM AND INCORPORATION BY REFERENCE

The present application is a continuation of U.S. patent applicationSer. No. 17/046,706, filed on Oct. 9, 2020, which is a 371 ofinternational application No. PCT/EP2019/059357, filed on Apr. 11, 2019,the contents of each of these priority applications are herebyincorporated by reference herein in their entirety as if fully set forthherein for all purposes. Any and all applications for which a foreign ordomestic priority claim is identified in the Application Data Sheet asfiled with the present application are hereby incorporated by referenceherein in their entirety and made a part of this specification.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to a vaginal device intended as an aid forwomen suffering from urinary stress incontinence.

Background of the Invention

Urinary incontinence is a public health issue which affects more than 13million women in the USA only. There exist different types of urinaryincontinence in women, such as urge incontinence, stress incontinenceand mixed incontinence. Women having urge incontinence suffer from atleast some unwanted leakage caused by urgency. The focus herein isurinary stress incontinence; however, the device is also likely torelieve urge incontinence. Of the number of women suffering from urinaryincontinence about half of them suffer from stress incontinence. Urinarystress incontinence is mainly caused by connective tissue laxity ordamage in the vagina or its supporting ligaments. The background tourinary stress incontinence and its origin may be described by theIntegral Theory (An integral theory and its method for the diagnosis andmanagement of female urinary incontinence, Petros P E, Ulmsten Ul, ScandJ Urol Nephrol Suppl, 1993; 153:1-93), which states that connectivetissue damage to the 3 zones of the Integral System, which encompassesall three pelvic organs, bladder, vagina and anorectum, is the ultimatecause of prolapse and dysfunction in these organs. In other words,stress incontinence may be caused by a defect function of the tissueand/or ligaments connecting the urethra and vaginal wall with the pelvicmuscles and pubic bone. Women having had vaginal delivery, have chroniccough, suffering from obesity or traumas to the pelvic floor are moreproned for stress incontinence. However, genetic factors may also be ofimportance and may cause these defect functions.

Today there exist surgical methods supported by the knowledge of theIntegral Theory. For example, U.S. Pat. No. 5,899,909 discloses asurgical method for restoration of incontinence, the today called TVT(tension free vaginal tape) method which is a method effectivelypreventing and eliminating stress incontinence. U.S. Pat. No. 5,899,909discloses a method comprising the steps of passing a tape into the bodyvia the vagina first at one end thereof and then at the other endthereof at one side and the other, respectively, of urethra to form aloop around urethra, located between urethra and the upper vaginal wall,extending said tape over the pubic bone and through the abdominal wall,the ends of the tape being available outside the abdominal wall,tightening said strap at said ends, and leaving the tape implanted inthe body. The tape is left permanently in the body to provide itself, asan artificial ligament, the reinforcement of the tissue required inorder to restore the urinary incontinence, and/or to provide saidreinforcement by the development of fibrous tissue.

The method disclosed according to U.S. Pat. No. 5,899,909 works verywell. However, it is a surgical method and as such it is not availablefor all women in need of help to reduce or eliminate stress incontinenceproblems. Since stress incontinence in women is an extensive, widelyspread problem all around the world, it is firstly not possible to treateveryone in need of a surgical treatment and secondly, in severalcountries, the possibility of receiving a TVT surgery is very limited.Moreover, many women sufferings from stress incontinence preferconservative treatment or are not suitable for TVT surgery, for instancedue to high age or wanting to give birth. Furthermore, in countries nothaving free medical service, or with only parts of that service beingfree, there will be many women having this problem but not the financialmeans to pay for a TVT surgery.

There exist today different devices with the purpose of alleviatingincontinence in women. U.S. Pat. No. 6,739,340 discloses a device forprevention of involuntary urination. The device comprises a body forarrangement in the vagina for compressive action on and support of theneck of the bladder and optionally the urethra. The body has asubstantially elongated shape with a longitudinal axis extending, in theintended direction of insertion, from a proximal to a distal end and ismade from a compressive and elastically deformable material. The bodycomprises at least one part which is protruding from the outer surfaceof the body which is said to provide at least one pressure area forcontact with the neck of the bladder and optionally the urethra.

U.S. Pat. No. 6,645,137 discloses a vaginal insert having a flexiblebody either in the form of a belt or a split cylinder. In either case,the insert may be into a coiled state. The body is said to have areduced diameter when coiled and exhibits a resilient bias towarduncoiling and expanding in diameter from the coiled state by beingrestricted by an applicator tube. When the insert is inserted into thevagina of a patient, it is said to expand and press against the vaginalwall, such as for treating incontinence. A medicament may be combinedwith the insert that is introduced to the patient through contact withthe insert, such as for treating incontinence with a drug as well aspressure. The belt-type body may incorporate mating ridges and groovesto keep the insert in a cylindrical shape. Latch elements may beincorporated on the insert to support the insert in an expanded,partially uncoiled state. There are disadvantages with the known vaginaldevices disclosed above. Firstly, none of these devices are securelyfixated inside of the vagina during normal use. When women move or forinstance exercise there exists a great risk for movement of thesedevices inside the vagina. Another circumstance when this problem may beextensive is during a sneeze when the pressure power inside of thevagina is very large. This may also render the vaginal devices beingpushed down towards the opening of the vagina. These cases of movementof the vaginal devices inside of the vagina render the pressingelements, that is the at least one protruding part in U.S. Pat. No.6,739,340 and the protruding coils in U.S. Pat. No. 6,645,137, of thevaginal devices to press on the wrong site of the vaginal wall orurethra. In those cases these vaginal devices have only limited effector no effect at all with respect to the prevention of stressincontinence. Moreover, both devices may be harmful for the patient orbe perceived as unpleasant to use. This is caused by the designs of thepressing elements of these vaginal devices.

WO2010074635 discloses a vaginal device for the prevention ofincontinence of the type called urinary stress incontinence, whichvaginal device may function as an alternative for a patient not suitablefor or one does not want to undergo a TVT surgery and which vaginaldevice solves the problems described above with up to now known vaginaldevices.

An object of the present invention is to provide an improved vaginaldevice which is more comfortable for the user and easier to handle.

SUMMARY OF THE DISCLOSURE

The object above is solved by a vaginal device of an elastic material,and wherein a portion of a longitudinal portion, between a supportingportion and a reference member has a decreasing cross-section towardsthe reference member. In some examples the portion has at least onenotch, groove or slot in an outer surface along an axial direction.

In a first aspect of the disclosure, a vaginal device for preventingurinary incontinence made of an elastic material is described. Thevaginal device may comprise a longitudinal portion having a geometricalcentre line, a first end and a second end, the first end being theinnermost of the vaginal device during use. The device may furtherinclude at least one supporting portion protruding from the longitudinalportion at the first end, the at least one supporting portion may beconfigured to support against the urethra, through the vaginal wall, ata site located adjacent the maximal urethral pressure point. The devicefurther may include a reference member protruding from the longitudinalportion at the second end, wherein the reference member during use maybe fixated against the vaginal introitus, holding the vaginal devicesecurely fixated inside of the vagina and ensuring the at least onesupporting portion may be arranged at the intended site. A section ofthe longitudinal portion, arranged between the at least one supportingportion and the reference member, may have a decreasing cross-sectiontowards the reference member and/or the section may have at least onenotch, groove and/or slot in an outer surface along an axial directionof the section.

In one example, the section of the longitudinal portion of the vaginaldevice may have a single notch, groove or slot. The single notch, grooveand/or slot provides the cross-section of the portion with a U-shapeand/or V-shape.

In one example, the section of the longitudinal portion of the vaginaldevice may have two notches, grooves and/or slots connected by twoarches, such as two arched surfaces. The arched surfaces have the shapeof extrados surfaces, i.e. an outer curve of an arch. The shape of thesurfaces connecting the two notches, grooves and/or slots may also bedescribed as two curved surfaces radially protruding from a centre line,such as two bulging surfaces or as surfaces having an arced shaped.

Alternatively, the shape of the section of the longitudinal portion maybe defined as at least sections of at least two longitudinally joinedcylinders, where the notches, grooves and/or slots are obtained betweenthe longitudinally joined sections of the cylinders. The diameters ofthe longitudinally joined cylinders may be the same, or they may bedifferent.

In one example may one of the two arches be longer than the other,whereby a cross-section of the section of the longitudinal portionresembles a key-hole shape.

In one example may the reference member be protruding at an angle fromthe longitudinal portion in a first direction towards the anus, when inuse, and/or a second direction towards the clitoris, when in use. Forexample, a first section of the reference member may be configured to beprotrude towards the anus, when in use and/or a second member of thereference member may be configured to protrude towards the clitoris,when in use.

In one example may a first section of the reference member protrudeslonger in a first direction towards the anus than a second directiontowards the clitoris.

In one example may the reference member have a curved top section and abottom section. The bottom section may have a flat shape. The curved topsection may be connected to the bottom section, at least to a first endof the bottom section which may protrude towards the anus, when in use,or to a second end of the bottom section which may protrude towards theclitoris, when in use. For example, the curved top section may beconnected to an end of the first section configured to protrude towardsthe anus, and/or to an end of the second section configured to protrudetowards the clitoris.

In one example may the reference member be widest at a connection pointwith the second end of the longitudinal portion.

In one example may the reference member be wider than the cross-sectionof the second end of the longitudinal portion at the connection point.

In another aspect of the disclosure is a method of preventing urinaryincontinence described. The method may comprise supporting the urethra,through the vaginal wall, at a site located adjacent the maximalurethral pressure point, by arranging at least one supporting portionprotruding from a longitudinal portion having a geometrical centre line,a first end and a second end, the first end being the innermost of thevaginal device during use. The method may further include fixating thesupporting portion at its intended site by arranging a reference memberprotruding from the longitudinal portion at the second end against thevaginal introitus, holding the vaginal device securely fixated inside ofthe vagina. The method may also include providing lower weight withmaintained stability by including a section of the longitudinal portionarranged between the at least one supporting portion and the referencemember, having a decreasing cross-section towards the reference memberand/or having at least one notch, groove and/or slot in an outer surfacealong an axial direction of the section.

In some examples may the intended site be located between close to themaximal urethral pressure point and the bladder neck.

As is mentioned above, during use, said at least one supporting portionof the vaginal device according to the present disclosure is intended tosupport against the urethra, through the vaginal wall, for example at asite located between close to the maximal urethral pressure point andthe bladder neck. The maximal urethral pressure point of the urethra issituated close to the middle point of the urethra or the mid urethra asit is also called. When a woman is about to sneeze or cough, thepressure built up along the urethra is the highest at this maximalurethral pressure point where the muscular pressure gets additionalforces from the bending of the proximal portion of urethra in downwarddirection at the “urethral knee”. The fixation of the distal portion ofa normal urethra at the “urethral knee” is due to the support from theposterior urethral ligaments on both sides of the urethra which connectthe symphysis pubis with the urethra and the anterior vaginal wall. Dueto compression of the urethra and a “curtsy effect” of the “urethralknee” during a pressure built up due to e.g. sneezing or coughing, thisarea is important to support so that the depression of the “urethralknee” decreases. This is accomplished by the at least one supportingportion of the vaginal device according to the present disclosure.Preferably, the at least one supporting portion according to the presentdisclosure supports against the urethra, through the vaginal wall, forexample against the maximal urethral pressure point or very close to it.At this site, the maximal effect is obtained. According to the presentdisclosure, however, the at least one supporting portion may alsosupport at sites between close to the maximal urethral pressure pointand the bladder neck, such as at several sites. Moreover, the expression“close to the maximal urethral pressure point” should in this case beinterpreted as possible sites on both sides of the maximal urethralpressure point, and not only on that side facing towards the bladderneck. The supporting portion of the vaginal device according to thepresent invention will support the lax urethra, through the vaginalwall, in cases of stress incontinence caused by laxity of the posteriorurethral ligaments. In rest there will be no or very little compressionof the urethra, which can interfere with the blood circulation. This isalso important due to the fact that the vaginal device according to thepresent invention should be comfortable to use. This is also adifference in comparison to vaginal devices according to state of theart which are stated to press against the urethra through the vaginalwall. Furthermore, the at least one supporting portion according to thepresent disclosure must be designed to be able to support the urethra attimes when the pressure built up is very high, such as when a woman isabout to sneeze. This supporting feature of the vaginal device accordingto the present disclosure requires that the at least one supportingportion is flexible in its nature, both in terms of material andconstruction, but also able to support the urethra at the intended sitewhen the pressure wave along the urethra is large. Another veryimportant difference of the vaginal device according to the presentdisclosure in comparison to known devices is the reference member of thepresent invention. The reference member protrudes from the longitudinalportion at the lower end and is fixated against the vaginal introitus.The reference member fixates the vaginal device in place so that the atleast one supporting portion supports the urethra at the intended site.This reference member is of great importance. When women are movingthere is an evident risk for vaginal devices to slide out of placeinside of the vagina. In such a case, when and if a pressure wave arisesfrom the abdomen, such as when sneezing or coughing, the vaginal devicewill not be fixated at the right place. This problem is solved by thevaginal device according to the present disclosure, having the referencemember making sure that the vaginal device and hence at least onesupporting portion to be fixated to support the urethra, through thevaginal wall, at the intended site.

Moreover, the fixation of the reference member against the vaginalintroitus is also of importance. The tissue against and around thevaginal introitus (labium minorae and majorae) shall be able to closearound the reference member, so that the reference member and vaginaldevice are fixated securely. This means that the fixation is made sothat the reference member is positioned at the labia minora, against thevaginal introitus, and not the labia majora. Due to the fact that labiamajora comprises fatty tissue and the size of the labia majora differs alot from woman to woman, it is difficult to design a reference memberfor fixation outside the labia majora.

The vaginal device according to the present disclosure may havedifferent design. For example, the at least one supporting portion doesnot have to protrude around the longitudinal portion. It is, however,important that the at least one supporting portion of the vaginal deviceprotrudes in the intended direction towards the urethra during use. Aslong as the at least one supporting portion is possible to supportagainst the urethra, through the vaginal wall, the design thereof mayvary. If the longitudinal portion has a larger diameter it is possibleto design the vaginal device so that the longitudinal portion in factsupports against the vaginal wall. In such a case, the at least onesupporting portion shall not protrude in all directions from thelongitudinal portion, that is, shall not protrude around thelongitudinal portion, due to the fact that the vaginal device as a wholein that case would not be able to be inserted in the vagina, or at leastwould not be comfortable to use. In such a case, the at least onesupporting portion may e.g. have a half-moon shape or the like so thatthe supporting portion only protrudes in an intended direction againstthe urethra. Many other shapes of the at least one supporting portionare also possible, such as flower-shaped and protruding around thelongitudinal portion, protruding around the longitudinal portionasymmetrically, but of course also a circular shaped disc which henceprotrudes symmetrically around the longitudinal portion. In the lattercase, the diameter of the longitudinal portion of course is smaller incomparison with the case of a half-moon shaped supporting portion due tothe fact that the at least one supporting portion protrudes around thelongitudinal portion and as such bears against the vaginal wall in alldirections.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which examples ofthe disclosure are capable of will be apparent and elucidated from thefollowing description of embodiments of the present disclosure,reference being made to the accompanying drawings, in which:

FIG. 1 is illustrating a side view of a vaginal device according to thepresent disclosure.

FIGS. 2 a and 2 b are illustrating examples of cross-sectional views ofthe longitudinal portions according to the disclosure.

FIGS. 3 a to 3 c are illustrating examples of a top view, a bottom viewand a cross-sectional view of a device according to the presentdisclosure.

FIGS. 4 a to 4 e are illustrating examples of the vaginal devicesaccording to the current disclosure.

DETAILED DESCRIPTION OF THE DISCLOSURE

Specific examples of the disclosure will be described with reference tothe accompanying drawings. This disclosure may, however, be embodied inmany different forms and should not be construed as limited to theembodiments set forth herein; rather, these embodiments are provided sothat this disclosure will be thorough and complete, and will fullyconvey the scope of the invention to those skilled in the art. Theterminology used in the detailed description of the embodimentsillustrated in the accompanying drawings is not intended to be limitingof the disclosure. In the drawings, like numbers refer to like elements.

The following description focuses on examples of the present disclosureapplicable to a vaginal device for preventing urge incontinence, stressincontinence and mixed incontinence. However, it will be appreciatedthat the disclosure is not limited to this application but may beapplied to many other types of symptoms which may be improved by supportof the urethra through the vaginal wall. As is mentioned above, thevaginal device according to the present disclosure is made of an elasticmaterial. The degree of hardness of materials possible to use for thevaginal device may be measured by shore A. Examples of possiblematerials may e.g. have a shore A of 10-50, e.g. 10-40, 10-30, 20-40 or20-30. According to another example of the present disclosure, thevaginal device is made of an elastic material of medical quality, thatis an inert material. Furthermore, the material may be roentgenvisualised. The latter may be of interest so that the vaginal device isvisible for X-ray examination so that it is possible to see where thevaginal device according to the present invention supports the urethra,through the vaginal wall. Examples of possible elastic materials, thatis elastic tissue accepted inert materials, are polyurethane, siliconerubber, latex rubber, polystyrene copolymer materials and naturalrubber, or combinations thereof. Other elastic tissue accepted inertmaterials are of course also possible to use.

As is mentioned above, the design of the supporting portion according tothe present disclosure may vary, but the important characteristic of theportion is the supporting feature. According to one example, the atleast one supporting portion is resilient in a radial direction towardsthe urethra through the vaginal wall. This implies that the supportingportion during support of the urethra, through the vaginal wall, mayfold itself somewhat in a radial direction, that is fold longitudinal tothe longitudinal portion. This may be of interest due to the fact thatthis may give an optimized support to the urethra without pressing toohard on the vaginal wall, and consequently the vaginal wall may not bedamaged by ischaemia. Moreover, it may also give an increased comfortfor the user in comparison to the known vaginal devices. The possibleradial resilience towards the urethra through the vaginal wall accordingto the present disclosure may also be something that differs from theknown vaginal devices, which only may give resilience in an axialdirection towards the urethra through the vaginal wall. This may beobserved by looking at the drawings of U.S. Pat. No. 6,739,340, showingat least one rigid pressing member of the device, which pressing memberonly is resilient due to use of a flexible material, as well as U.S.Pat. No. 6,645,137, which discloses pressing rigid rings of a similartype as is disclosed according to U.S. Pat. No. 6,739,340.

The at least one supporting portion according to the present disclosuremay, however, also be of a more rigid type, such as the ones disclosedaccording to U.S. Pat. Nos. 6,739,340 and 6,645,137. The choice of theelastic material and the hardness thereof of the vaginal device areimportant in this sense. A thick at least one supporting portion is e.g.possible according to the present invention if a soft elastic materialhaving a low hardness (shore A) is chosen for the vaginal device. Thisgives a supporting portion which is not resilient in a radial directiontowards the urethra through the vaginal wall, but due to the choice of asoft elastic material, the supporting portion may give both enoughsupport to the urethra, through the vaginal wall, and still be harmlessto the vaginal wall and comfortable to use. The choice of the design ofthe at least one supporting portion according to the present disclosuredepends in other words on several parameters, such as if only onesupporting portion is intended, the material of the vaginal device andhence supporting portion or portions and the thickness and materialthereof. As mentioned above, the design of the at least one supportingportion may vary. According to one example of the present disclosure,the at least one supporting portion protrudes all around thelongitudinal portion. This implies that the at least one supportingportion or supporting member e.g. may look like flower-shaped or like acircular disc if the vaginal device is viewed from above. According toanother example of the disclosure, the at least one supporting portionprotrudes all around the longitudinal portion and is substantiallycircular in a plane perpendicular to the geometrical centre line. Thisimplies a disc-like supporting portion disclosed above. Moreover, thevaginal device according to the present disclosure may be provided withsome specific features. According to one example, the vaginal device ofthe present disclosure comprises at least one perforation going throughthe at least one supporting portion. This at least one perforation maybe provided to avoid a feel of suction/vacuum upon removal of thedevice.

The size of the different parts of the vaginal device may vary. Forexample, the diameter of the vaginal device, especially at its widestplace, may vary. This is due to the fact that the size of vaginas ofwomen may vary. Therefore, according to one example, the at least onesupporting portion protrudes all around the longitudinal portion, issubstantially circular in a plane perpendicular to the geometricalcentre line and has a diameter of 25-45 mm, such as 25-40 mm, 25-35 mm,30-45 mm, 30-35 mm, 35-45 mm, 35-40 mm, 40-45 mm. Examples of somepossible diameters are 30, 35 and 40 mm. Although this example disclosesat least one supporting portion or supporting member being substantiallycircular, other shapes are possible as well, such as the flower-shapedsupporting portion mentioned above. In such a case, the diameter shouldbe interpreted as the length from a most protruding point of thesupporting portion on one side of the longitudinal portion to anothermost protruding point of the supporting portion on the other side of thelongitudinal portion, through a geometrical centre inside of thelongitudinal portion.

As said above, the diameter of the longitudinal portion may vary,dependent inter alia on if the supporting portion is protruding allaround the longitudinal portion. According to one example of the presentdisclosure, the longitudinal portion is circular and has a diameter of10-20 mm, such as 10-15 mm, 15-20 mm, e.g. 15 mm. A substantiallycircular cross section of the longitudinal portion is advantageous dueto the fact of a better fit inside of the vagina.

The length of the vaginal device may also vary. However, there exists alower possible threshold due to the fact that the vaginal device shouldmake it possible for the supporting portion to support at the possibleintended sites of the urethra. An upper limit exists also due to obviousreasons. This upper limit is about 90 mm since the normal length of thevagina up to the anterior fornix is about that length in rest. Accordingto one example of the present disclosure, the longitudinal portion has alength of 40-80 mm from a first end to a second end, the first end beingthe innermost of the vaginal device during use, such as 40-80 mm, 40-70mm, 45-60 mm, e.g. 50 mm. According to yet another example of thepresent disclosure, the distance from the second end of the longitudinalportion to the centre of the first (as seen from the second end) of theat least one supporting portion, at the geometrical centre line, is15-55 mm, such as 15-50 mm, 15-45 mm, 15-40 mm, 15-35 mm, 15-30 mm,15-25 mm, 20-55 mm, 20-50 mm, 20-45 mm, 20-40 mm, 20-35 mm, 20-30 mm.

According to the present disclosure, there may be provided more than onesupporting portion or supporting member along the longitudinal portion.Therefore, according to one example of the present disclosure, thevaginal device comprises at least two supporting portions protrudingfrom the longitudinal portion, the at least two supporting portionsprotruding separately from each other along the longitudinal portion andall of the at least two supporting portions being intended to supportagainst the urethra, through the vaginal wall, for example at siteslocated between close to the maximal urethral pressure point and thebladder neck.

According to one example of the present disclosure, the vaginal devicecomprises two supporting portions protruding from the longitudinalportion, wherein the two supporting portions protrude separately fromeach other along the longitudinal portion. The distance between the twosupporting portions or supporting members may in this specific casevary, but as an example the distance between these two may be about 8-12mm, such as 9-11 mm, such as about 10 mm, from a geometrical middlepoint of the second supporting portion to a geometrical middle point ofthe first supporting portion. This distance corresponds to that of thevaginal tape used in a TVT surgery, and with two supporting portionswhich are resilient in a radial direction towards the urethra throughthe vaginal wall, circularly shaped and hence protruding around theentire longitudinal portion, these may together support the urethra,through the vaginal wall, at the same site of the urethra as the TVTtape stabilises. To achieve this effect and to achieve an elevatedresilient effect, it may be advantageous to provide two supportingportions, in the shape of circular discs described above, which protrudeseparately from each other along the longitudinal portion and which mayhave a thickness of about 3-5 mm, such as about 4 mm.

According to one example of the present disclosure, the vaginal devicecomprises two supporting portions protruding from the longitudinalportion, the at least two supporting portions protruding separately fromeach other along the longitudinal portion and both of the at least twosupporting portions being intended to support against the urethra,through the vaginal wall, at two sites located, for example betweenclose to the maximal urethral pressure point and the bladder neck.

The design of the reference member according to the present disclosuremay also vary. According to one example, the reference member may have afirst section configured to protrude towards the anus, when in use, andoptionally a second section configured to protrude towards the clitoris,when in use. The first section of the reference member may protrudeabout 20-40 mm, such as 25-35 mm, such as about 30 mm from thegeometrical centre line of the longitudinal portion at the second end,and the second section of the reference member may protrude below 25 mm,such as e.g. 10-25 mm, 10-20 mm, 15-25 mm, e.g. 15 mm, from thegeometrical centre line of the longitudinal portion at the second end.The meaning of the first section of the reference member, and the secondsection of the reference member may be understood by viewing theaccompanied drawings. The first section of the reference member is thatend that will be fixated against the perineum by the user. The secondsection of the reference member is that end facing towards the oppositedirection, that is towards the clitoris but not reaching the same. Thisis the reason for the different length thresholds for the protrusion ofthe first and second section, respectively. About 25-35 mm, such as 30mm, has proven to be a functional length for the first section of thereference member from the centre line of the longitudinal portion sothat the reference member is possible to fixate against the perineum bythe user in a functional way. The second section of the reference memberhas as mentioned a length below 25 mm from the centre line of thelongitudinal portion. This is due to that the second section of thereference member should be short enough not to irritate the clitoris ofa user. However, even if a vaginal device according to the presentdisclosure without a second section configured to protrude toward theclitoris, when in use, of the reference member is possible, such asecond section may increase the stability and hence fixation of theentire vaginal device inside of the vagina during use. Without thesecond section of the reference member there may be some risk for thevaginal device to sway and as such fall somewhat out of the perfectposition inside of the vagina, e.g. during substantial movement. Theshape of the first section and second section of the reference membermay e.g. be ribbons which have widths that are smaller than the diameterof the longitudinal portion.

According to one example of the present disclosure, the reference memberhas a first and a second section, the first section is configured toprotrude about 20-40 mm from the geometrical centre line of thelongitudinal portion at the second end and the second section isconfigured to protrude about 10-25 mm from the geometrical centre lineof the longitudinal portion at the second end. 20-40 mm, such as 25-35mm, 25-30 mm, e.g. about 30 mm, is a length interval of the firstsection of the reference member which may be suitable for an elevatedfixation of the reference member. Moreover, about 10-25 mm, such as10-20 mm, 10-15 mm, 15-25 mm, 15-20 mm, e.g. about 15 mm, is a lengthinterval of the second section of the reference member which is enoughfor achieving good fixation of the vaginal device inside of the vaginawithout any risk for any swaying during powerful movement by the user,but at the same time is short enough not to irritate the clitoris of theuser. The reference member of the vaginal device according to thepresent disclosure functions as a means for insertion and pulling outthe vaginal device. The shape of the reference member may vary, but asuitable example is as a ribbon which has the same width or a thinnerwidth than the longitudinal portion of the vaginal device according tothe present disclosure. According to one example, the reference memberis concave. This means that both of the first section and the secondsection of the reference member may have this concave shape. Thepossible concave shape of the first section and possibly also theshorter second section of the reference member, means that these endsbend somewhat towards the first end of the longitudinal portion. Thebending or curvature in this case may not very large. This concave shapeof the reference member may increase the stability and fixation of thevaginal device during use. Detailed description of the drawings FIG. 1illustrates one example of a vaginal device 1 according to the presentdisclosure. The vaginal device 1 may comprise a longitudinal portion 2having a geometrical centre line 3, a first end 4 and a second end 5.Moreover, the vaginal device 1 may comprise at least one supportingportion 6 protruding from the longitudinal portion 2. In this case thevaginal device 1 according to the present disclosure may have twocircular supporting portions 6, one second 8 having a centre 11 alongthe geometrical centre line 3 and one first 10 having a centre 9 alongthe geometrical centre line 3, the supporting portions 6 may protrudesymmetrically around the longitudinal portion 2. The vaginal device 1may also comprise a reference member 7 protruding from the longitudinalportion 2 at the second end 5. During use, the reference member 7 mayfixated against the vaginal introitus, holding the vaginal device 1securely fixated inside of a vagina and ensuring the two supportingportions 6 to support against the urethra, through the vaginal wall, atan intended site located, for example between close to the maximalurethral pressure point and the bladder neck, preferably located at themaximal urethral pressure point. In this specific case, the referencemember 7 may have first section 12 configured to protrude towards theanus, when in use, and a second section 13 configured to protrudetowards the clitoris, when in use. The first section 12 being intendedto be fixated against the perineum by the user and if done, the secondsection 13 of the reference member may then end facing towards theopposite direction, that is towards the clitoris but not reaching thesame.

The vaginal device 1 according to the example illustrated in FIG. 1 mayhave a section 21 of the longitudinal portion 2 configured to lower theweight of the product without sacrificing the stability of the vaginaldevice 1, thereby increase the comfort for the user. This may beprovided, for example, by configuring the section 21 of the longitudinalportion 2, between the at least one supporting portion 6, such as thefirst supporting portion 10, and the reference member 7 to have adecreasing cross-section towards the reference member 7. In a furtherexample, the section 21 of the longitudinal portion 2 may additionallyand/or alternatively have at least one notch, groove and/or slot in anouter surface along an axial direction of the centre line 3.

Additionally, in one example of the vaginal device, the reference memberor the whole device is coated with a hydrophilic lubricious coating,making the device slippery when wet and thereby reducing the friction onthe labia. The friction may be almost removed. Examples of such coatingmaterials are ISurTec® and AquaGlide®.

FIGS. 2 a and 2 b are illustrating two examples of cross-sections. FIG.2 a is illustrating an example wherein section 21 has a single notch,groove and/or slot 22, and the single notch, groove and/or slot providesa cross-section of the portion 21 with a U-shape or V-shape. In theillustrated example, may the opening of the U-shape and/or V-shape be indirected towards the clitoris, but the opposite may also be possible.

FIG. 2 b is illustrating an example wherein the section 21 has twonotches, grooves or slots 22 a, 22 b connected by two arches 23 a, 23 b,such as two arched surfaces. The arched surfaces 23 a, 23 b have theshape of extrados surfaces, i.e. an outer curve of an arch. The shape ofthe surfaces connecting the two notches, grooves and/or slots 22 a, 22 bmay also be described as two curved surfaces 23 a, 23 b radiallyprotruding from a centre line 3, such as two bulging surfaces or assurfaces having an arced shaped. Alternatively, the shape of the section21 of the longitudinal portion 2 may be defined as at least sections ofat least two longitudinally joined cylinders 23 a, 23 b, where thenotches, grooves and/or slots 22 a, 22 b are obtained between thelongitudinally joined sections of the cylinders. The diameters of thelongitudinally joined cylinders may be the same, or they may bedifferent.

Additionally, in some examples, the section 21 is solid. In someexamples the longitudinal portion 2 is solid.

In the illustrated example, one of the arches 23 a is longer than theother arch 23 b, whereby a cross-section of the section 21 resembles akey-hole shape. In the illustrated example is the section 21 configuredso that the shorted arch 23 b may be arranged in a direction towards theclitoris and the longer arch 23 a in a direction towards the anus.According to other examples, the opposite may also be possible.

The cross-sectional shapes illustrated in FIGS. 2 a and 2 b makes itpossible to make the longitudinal portion 2 thinner compared to previousdevices with maintained stability. Thereby provide a lower weight. Italso provides the possibility of making section 21 with a cross-sectionwhich decreases towards the reference member 7. The cross-sections willalso provide lower weight but also improved comfort for the user of thedevice.

Other cross-sectional shapes may also be viable, for example withfurther notches, grooves and/or slots and arches to have thecross-section of the section 21 to resemble a clover leaf, or aflower-like shape.

The width and height of the cross-section of the section 21 may besymmetric so that the width and height are the same. In some examples,the height, i.e. in a clitoris to anus direction, may be longer than thewidth of the cross-section. In other examples, the symmetry could havemore of a triangular shape.

FIG. 3 a is illustrating the vaginal device 1 of FIG. 1 seen from thesecond end 5. The reference member 7 may also be the bottom section 15of the reference members 7 illustrated in FIGS. 4 a to 4 e . Thereference member 7 may have an oval, elliptic or oblong shape to providegood fixation against the vaginal introitus.

FIG. 3 b is illustrating the vaginal device 1 in FIG. 1 seen from thefirst end 4.

FIG. 3 c is illustrating the bottom side of the reference member 7. Insome example may the reference member 14 be wider than the endcross-section of the longitudinal portion 2 at a connection point 14.This may improve fixation against the vaginal introitus thereby improvestability of the vaginal device 1 when in use. In some other examplesmay the widest portion of the reference member 7 be at the middle of thereference member 7. Alternatively, in some other examples may the widestportion of the reference member 7 be at connection point 14, therebyproviding a connection point 14 where the reference member 7 is widerthan the cross-section of the end portion of the longitudinal portion 2.

As illustrated in FIG. 3 c , the reference member 7 may be taperedtowards an end of the first section 12 of the reference member 7 and/oran end of the second section 13 of the reference member 7. Further, thelonger sides 24 of the reference member 7 may be tapered to make theedge thinner. This will improve the flexibility of the reference memberand may improve the fixation against the vaginal introitus. Inparticular the bottom of the reference member 7 may have bevelled edges.The bevelled edges may be rounded while inclining towards the edge. Atapered or bevelled edge, especially of the longer sides 24 of thereference member 7, may improve the fixation against the vaginalintroitus.

FIGS. 4 a to 4 e are illustrating alternative examples of the referencemember 7 illustrated in FIG. 1 . FIG. 4 a is illustrating a referencemember 7 which includes a bottom section 15, similar to the referencemember 7 as illustrated in FIGS. 1, and 3 a to 3 c. The reference member7 further includes a top section 16 which is curved to be connected toat least an end of the first section 12 of the bottom section 15,configured to be directed towards the anus, or an end of the secondsection 13 of bottom section 15, configured to be directed towards theclitoris. The bottom section 15, which may have a flat shape, and thecurved top section 16 enclose an area 17. The area 17 may be hollow asillustrated in FIG. 4 c . Alternatively the area may have a shallowdepression 18 as illustrated in FIG. 4 d.

The curved top section 16 is made to improve the handling of the vaginaldevice when positioning and removing the vaginal device. While a hollowarea 17 allows for a light weighted vaginal device wherein the curvedtop section 16 is flexible and may be compressed against the bottomsection 15 allowing a low profile, a depression 18 provides an improvedstability of the reference member 7.

FIG. 4 e is illustrating an example where the curved top section 19 isonly connected or hinged to the bottom section 15 at the r end of thesecond section 13 and with a gap between the curved top section 19 andthe bottom section 15 at the end of the first section 12. This providesfurther improvements on the flexibility of the curved top section 19 andalso provides a lighter weight. A configuration where the curved topsection 19 is only connected or hinged at one end of the bottom section15 may also make the vaginal device easier to remove. Since the curvedtop section 15 may work as a string. The curved top section 19 may insome examples be connected at the end of first section 12 of the bottomsection 15 which will give similar properties as when the curved topsection 19 is connected to the end of the second section 13 of thebottom section 15. But the handling of the device may be slightly betterwhen the curved top section 15 is connected to the end of the secondsection 13 of the bottom section 15. Especially for removal of thevaginal device.

While several examples of the present disclosure have been described andillustrated herein, those of ordinary skill in the art will readilyenvision a variety of other means and/or structures for performing thefunctions and/or obtaining the results and/or one or more of theadvantages described herein, and each of such variations and/ormodifications is deemed to be within the scope of the presentdisclosure. More generally, those skilled in the art will readilyappreciate that all parameters, dimensions, materials, andconfigurations described herein are meant to be exemplary and that theactual parameters, dimensions, materials, and/or configurations willdepend upon the specific application or applications for which theteachings of the present disclosure is/are used.

The invention claimed is:
 1. A method of preventing urinaryincontinence, the method comprising: supporting the urethra, through thevaginal wall, at a site located adjacent the maximal urethral pressurepoint, by arranging at least one supporting portion protruding from alongitudinal portion, the longitudinal portion having a geometricalcentre line, a first end and a second end, the first end being theinnermost of the vaginal device during use; fixating the supportingportion at its intended site by arranging a reference member protrudingfrom the longitudinal portion at the second end against the vaginalintroitus, holding the vaginal device securely fixated inside of thevagina; wherein a section is arranged between the at least onesupporting portion and the reference member, having a decreasingcross-section towards the reference member and/or having at least onegroove in an outer surface along an axial direction of the section. 2.The method of claim 1, arranging the reference member to protrude at anangle from the longitudinal portion in a first direction towards theanus.
 3. The method of claim 1, arranging the reference member toprotrude at an angle second direction towards the clitoris.
 4. A methodof preventing urinary incontinence using the vaginal device, the vaginaldevice is made of an elastic material, the vaginal device comprises: alongitudinal portion having a geometrical centre line, a first end and asecond end, the first end being the innermost of the vaginal deviceduring use; at least one supporting portion protruding from thelongitudinal portion at the first end, the at least one supportingportion being configured to support against the urethra, through thevaginal wall, at a site located adjacent the maximal urethral pressurepoint; a reference member protruding from the longitudinal portion atthe second end, wherein the reference member during use is fixatedagainst the vaginal introitus, holding the vaginal device securelyfixated inside of the vagina and ensuring the at least one supportingportion is arranged at the intended site; wherein a section of thelongitudinal portion, arranged between the supporting portion and thereference member, has a decreasing cross-section towards the referencemember and/or has at least one groove in an outer surface along an axialdirection of the section; the method comprising: supporting the urethra,through the vaginal wall, at a site located adjacent the maximalurethral pressure point, by arranging the at least one supportingportion; and fixating the supporting portion at its intended site byarranging the reference member protruding from the longitudinal portionat the second end against the vaginal introitus, holding the vaginaldevice securely fixated inside of the vagina.
 5. The method of claim 4,wherein the section of the longitudinal portion has two groovesconnected by two arched surfaces.
 6. The method of claim 4, wherein oneof said two arched surfaces is longer than the other, whereby across-section of the portion resembles a key-hole shape.
 7. The methodof claim 4, wherein the section of the longitudinal portion has a shapedefined as at least sections of at least two longitudinally joinedcylinders, where at least two grooves are obtained between thelongitudinally joined sections of the cylinders.
 8. The method of claim4, wherein at least one of the cylinders has a diameter different fromthe other.
 9. The method of claim 4, wherein the reference member isprotruding at an angle from the longitudinal portion in a firstdirection towards the anus, when in use, and/or a second directiontowards the clitoris, when in use.
 10. The method of claim 4, whereinthe reference member protrudes longer in the first direction than thesecond direction.
 11. The method of claim 4, wherein the referencemember has a curved top section and a bottom section, and wherein thecurved top section is connected to the bottom section to at least afirst end of the bottom section protruding towards the anus, when inuse, an/or to a second end of the bottom section protruding towards theclitoris, when in use.
 12. The method of claim 4, wherein the referencemember is widest at a connection point with the second end of thelongitudinal portion.